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Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

Primary Purpose

Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous positive airway pressure
Incentive spirometry
Breath Stacking
Expiratory Positive Airway Pressure
Intermittent positive pressure breathing
Bi-level positive airway pressure
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Morbid obesity, Bariatric surgery, Pulmonary atelectasis, Spirometry, Continuos Positive Airway Pressure, Physical therapy speciality

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 40 and 55 Kg/m²
  • Aged between 25 and 55 years
  • Submitted to Roux-en-Y type gastric by-pass by laparotomy
  • Normal preoperative pulmonary function test

Exclusion Criteria:

  • Hemodynamic instability
  • Hospital stay longer than three days
  • Presence of postoperative complications
  • Smoking

Sites / Locations

  • Universidade Metodista de Piracicaba (UNIMEP)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Incentive spirometry (Voldyne®)

Continuous positive airway pressure

Expiratory Positive Airway Pressure

Intermittent positive pressure breathing

Bi-level positive airway pressure

Breath Stacking

Control

Arm Description

Individuals will be treated with incentive spirometry, Voldyne Model 5000® in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.

Individuals will be treated with flow generator(Whisperflow, Caradyne, Ireland)and valve PEEP type spring-loaded which remain 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.

Subjects will be treated with oronasal mask affixed to the face, with the PEEP valve set at 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.

Subjects will be treated with application of Müller Resuscitator (Engesp®) through a nozzle, using a pressure endotracheal 20-30 cmH2O, refering to 2-3 kgf/cm², adjusted throttle valve oxygen, according to the patient's comfort and the micronebulizer coupled only saline as the diluent. The procedure will be performed in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.

Individuals will be treated with positive pressure in the BiPAP mode (Bi-level positive airway pressure) in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.

Subjects will be treated with a siliconized mask connected to a unidirectional valve and adapted to the patient's face, allowing only the inspiration and the expiratory limb remains occluded, while the volunteer is instructed to perform successives inspiratory efforts, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.

Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Outcomes

Primary Outcome Measures

Pulmonary function
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.

Secondary Outcome Measures

Prevalence of atelectasis
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Thoracoabdominal mobility
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Peak cough flow
The peak flow measured during a cough maneuver will be measured by the equipment Peak Flow ®. For this, the volunteer will be instructed to place the mouthpiece between the lips of the equipment and play a cough with nostrils occluded nose clip. The maneuver should be repeated three times and the best preoperative measures will be compared to the best postoperative measurement.

Full Information

First Posted
June 4, 2013
Last Updated
December 2, 2013
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01872663
Brief Title
Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery
Official Title
Influence of Different Physical Therapy Resources Application After Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty. It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.
Detailed Description
The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative. Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included. The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery: G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration). The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
Keywords
Morbid obesity, Bariatric surgery, Pulmonary atelectasis, Spirometry, Continuos Positive Airway Pressure, Physical therapy speciality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive spirometry (Voldyne®)
Arm Type
Experimental
Arm Description
Individuals will be treated with incentive spirometry, Voldyne Model 5000® in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Arm Title
Continuous positive airway pressure
Arm Type
Experimental
Arm Description
Individuals will be treated with flow generator(Whisperflow, Caradyne, Ireland)and valve PEEP type spring-loaded which remain 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.
Arm Title
Expiratory Positive Airway Pressure
Arm Type
Experimental
Arm Description
Subjects will be treated with oronasal mask affixed to the face, with the PEEP valve set at 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Arm Title
Intermittent positive pressure breathing
Arm Type
Experimental
Arm Description
Subjects will be treated with application of Müller Resuscitator (Engesp®) through a nozzle, using a pressure endotracheal 20-30 cmH2O, refering to 2-3 kgf/cm², adjusted throttle valve oxygen, according to the patient's comfort and the micronebulizer coupled only saline as the diluent. The procedure will be performed in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Arm Title
Bi-level positive airway pressure
Arm Type
Experimental
Arm Description
Individuals will be treated with positive pressure in the BiPAP mode (Bi-level positive airway pressure) in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.
Arm Title
Breath Stacking
Arm Type
Experimental
Arm Description
Subjects will be treated with a siliconized mask connected to a unidirectional valve and adapted to the patient's face, allowing only the inspiration and the expiratory limb remains occluded, while the volunteer is instructed to perform successives inspiratory efforts, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.
Intervention Type
Procedure
Intervention Name(s)
Continuous positive airway pressure
Intervention Description
The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
Intervention Type
Procedure
Intervention Name(s)
Incentive spirometry
Intervention Description
The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.
Intervention Type
Procedure
Intervention Name(s)
Breath Stacking
Intervention Description
The method allowed to obtain a maximum lung expansion with minimal patient compliance.
Intervention Type
Procedure
Intervention Name(s)
Expiratory Positive Airway Pressure
Intervention Description
The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
Intervention Type
Procedure
Intervention Name(s)
Intermittent positive pressure breathing
Intervention Description
The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
Intervention Type
Procedure
Intervention Name(s)
Bi-level positive airway pressure
Intervention Description
The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
Primary Outcome Measure Information:
Title
Pulmonary function
Description
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Time Frame
2 days after surgery
Secondary Outcome Measure Information:
Title
Prevalence of atelectasis
Description
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Time Frame
2 days after surgery
Title
Thoracoabdominal mobility
Description
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Time Frame
2 days after surgery
Title
Peak cough flow
Description
The peak flow measured during a cough maneuver will be measured by the equipment Peak Flow ®. For this, the volunteer will be instructed to place the mouthpiece between the lips of the equipment and play a cough with nostrils occluded nose clip. The maneuver should be repeated three times and the best preoperative measures will be compared to the best postoperative measurement.
Time Frame
2 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 40 and 55 Kg/m² Aged between 25 and 55 years Submitted to Roux-en-Y type gastric by-pass by laparotomy Normal preoperative pulmonary function test Exclusion Criteria: Hemodynamic instability Hospital stay longer than three days Presence of postoperative complications Smoking
Facility Information:
Facility Name
Universidade Metodista de Piracicaba (UNIMEP)
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13400911
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25590448
Citation
Brigatto P, Carbinatto JC, Costa CM, Montebelo MI, Rasera-Junior I, Pazzianotto-Forti EM. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial. Braz J Phys Ther. 2014 Nov-Dec;18(6):553-62. doi: 10.1590/bjpt-rbf.2014.0054. Epub 2015 Jan 9.
Results Reference
derived

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Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

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